According to a study the bipolar patients who received Pfizer Inc's atypical antipsychotic ziprasidone showed significant improvement in symptoms of acute mania compared with those who received placebo. Results from this randomized, double-blind, placebo-controlled study demonstrated that ziprasidone produced rapid, sustained improvements in manic symptoms when compared to placebo. Significant improvements were observed within two days of treatment and were maintained throughout the three-week study.
The study, which involved 210 inpatients, also demonstrated that after 7 days of treatment ziprasidone-treated patients showed significant improvement across all evaluation scales compared to those who took placebo, including symptoms of acute mania, psychosis and social functioning.
Bipolar disorder, which is also referred to as manic-depressive illness, is a serious form of mood disorder in which patients may experience extreme 'highs,' or manic episodes, and extreme 'lows,' or periods of major depression. The condition is estimated to affect one in every 100 Americans and has a major impact on the ability to function in daily life. Bipolar disorder is estimated to cost society about $45 billion per year.
Patients in the midst of a period of mania, which usually lasts at least a week, may appear to be overly energetic, extremely expansive or excessively happy. They may have difficulty sleeping, functioning in social or work situations and may overindulge in pleasurable activities.
The study was conducted in the United States and Brazil. Ziprasidone patients began taking 80 mg per day and were quickly titrated to 160 mg per day by the second day. Dosing was then flexible for the remainder of the study. Efficacy was measured using standardized psychiatric assessment scales.
Among ziprasidone-treated patients, there was a low incidence of movement disorders, a side-effect associated with some atypical antipsychotic medications and no clinically significant weight gain, changes in vital signs or other safety parameters. The most common side effects of ziprasidone in this study included somnolence, headache, dizziness, hypertonia, nausea and akathisia.
Discovered and developed by Pfizer, ziprasidone is a serotonin and dopamine antagonist. The medicine was approved by the U.S. Food and Drug Administration in February 2001 for use in the treatment of schizophrenia. It also is approved in more than 45 countries worldwide.
Ziprasidone received approval for the treatment of acute mania in Brazil in November 2002. Pfizer plans to file a supplemental new drug application FDA later this year for the treatment of acute mania. Ziprasidone is currently marketed as Geodon in the United Sates and in Brazil.
Oral ziprasidone is associated with a prolongation of the QTc interval of the electrocardiogram, an effect seen with certain other marketed medicines, including some antipsychotics. This effect was well characterized in the extensive oral ziprasidone trials database and is reflected in the FDA's product labeling, which suggest that physicians use their best judgment as to whether ziprasidone is the appropriate medication based on the overall status of the patient.